Anti-Cytokine Therapy for Hemodialysis InflammatION

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

December 15, 2017

Primary Completion Date

September 2, 2021

Study Completion Date

September 2, 2021

Conditions
End-Stage Renal Disease
Interventions
DRUG

Anakinra

Anakinra (Kineret®) is a therapeutic agent that blocks the effects of IL-1α and IL-1β by competitively binding to the interleukin-1 type I receptor (IL-1RI). It is a recombinant, non-glycosylated form of the naturally occurring human interleukin-1 receptor antagonist (IL-1Ra) but differs from human IL-1Ra in that it has the addition of a single methionine residue at the amino terminus. It is supplied commercially in single use 1 ml prefilled glass syringes as a sterile, clear, colorless-to-white, preservative free solution. Each syringe contains: 0.67 ml (100 mg) of anakinra in a solution (pH 6.5) containing sodium citrate (1.29 mg), sodium chloride (5.48 mg), disodium EDTA (0.12 mg) and polysorbate 80 (0.70 mg) in Water for Injection, USP.

DRUG

Placebo

Saline (0.9%) will be used as the placebo, in single use 1 ml prefilled glass syringes as a sterile, clear, colorless-to-white, preservative free solution.

Trial Locations (4)

20037

The George Washington University, Washington D.C.

37232

Vanderbilt University Medical Center, Nashville

98104

University of Washington Kidney Research Institute, Seattle

02120

Brigham & Women's Hospital, Boston

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of Pennsylvania

OTHER

NCT03141983 - Anti-Cytokine Therapy for Hemodialysis InflammatION | Biotech Hunter | Biotech Hunter